Sick Sinus SyndromeCIED-CARENCT06652750
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
A study testing Routine Management and 5G Cloud Follow-up in people with Sick Sinus Syndrome and Atrioventricular Block, Second and Third Degree, run by The Third People's Hospital of Chengdu at 2 sites in China.
Trial summary
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- What is being tested?
- Routine Management and 5G Cloud Follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 2 sitesChina
- Study dates
- 13 Nov 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, gender unspecified;
- Patients who have not undergone their first clinic follow-up after the implantation of cardiovascular implantable electronic devices (CIED); Note: In this study, CIED includes pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D), excluding implantable cardiac event recorders (ICM) and implantable cardiovascular monitors.
- Willing to participate in this clinical study and have signed the informed consent form in writing.
Who cannot join
- If meeting any of the following, the individual cannot be included:
- Life expectancy < 1 year.
- Inability to cooperate with treatment or follow-up, such as having mental illness.
- Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan, 610000
Yan Luo, master of medicine, 8618090809034, luoyan31566@163.com
Lin Cai, master of medicine
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Juan Lei, 8613650894373, leijuan@mail.sysu.edu.cn
Shuxian Zhou, MD
About this study
Official title: Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices: a Prospective, Paired, Self-controlled, Non-inferiority, Multicenter Clinical Trial
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation.
Participants will:
undergo regular clinic follow-up visits in accordance with the guidelines undergo routine in-office follow-up and 5G cloud follow-up during each regular clinic visit
Read the detailed description
Background: Cardiovascular implantable electronic devices (CIED) include pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) pacemakers and defibrillators, implantable cardiac event recorders (ICM), and implantable cardiovascular monitors. They are mainly used for the diagnosis, monitoring, and treatment of bradycardia, tachycardia, and heart failure (HF). There are currently two main methods of follow-up: routine in-office follow-up and remote monitoring (RM). Routine in-office follow-up is the most commonly used method in China, whereby professional doctors and/or manufacturer engineers conduct follow-ups under the guidance of physicians. Remote monitoring (RM) allows patients to be remotely monitored at home or elsewhere when a communication network is available, receiving periodic alerts related to the patient. Remote monitoring (RM) can provide timely and accurate CIED data and information, promptly alerting clinical doctors to any issues. However, a drawback is that patients still need to visit the hospital for device parameter adjustments, so it only partially fulfills the functions of routine in-office follow-up. Of note, in the past three years, some domestic clinical centers in China have begun exploring the application of 5G cloud follow-up remote programming (5G Cloud Follow Up) in various patient follow-up scenarios. With the comprehensive deployment of 5G networks in China, central hospitals with specialized device programmers can establish one-to-one or one-to-many regional collaborative cloud follow-up systems with primary hospitals lacking follow-up technician through 5G networks. CIED patients only need to visit nearby primary hospitals to complete regular device follow-ups. Currently, excellent research results have been obtained in the quality control of the CIED follow-ups of a single provincial medical consortium system mainly consisting of major implantation centers. However, there is still a lack of verification results for 5G cloud follow-up remote programming in a medical consortium (MC) model covering various administrative regions in China and different levels of primary hospitals. This study will compare the safety and effectiveness of using 5G cloud follow-up remote programming in different administrative regions and levels of primary hospitals in China with routine in-office follow-ups.
Objective:
This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation.
Participants will:
undergo regular clinic follow-up visits in accordance with the guidelines undergo routine in-office follow-up and 5G cloud follow-up during each regular clinic visit
- Being tested
- Routine Management, 5G Cloud Follow-up
- Keywords
- pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy, follow up, remote programming, in-office follow-up
- Medical subject headings
- Sick Sinus Syndrome, Atrioventricular Block, Neoplasm Metastasis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine ManagementOther
Conducting routine in-office follow-up for CIED paitents
5G Cloud Follow-upDevice
This study employed a 5G-cloud follow-up platform, a research tool that allows a device specialist to test, and program CIEDs in real-time from a remote location via an internet connection or mobile wireless network. Consistent with of the 5G remote support terminal externally connected to the programmer, a PAD was installed with a 5G-cloud follow-up app. The onsite medical staff began the cloud follow-up session by contacting the remote device specialist via video call. The connection to the CIED was made by the medical staff through the use of a standard programmer. He was in charge of turning on the programmer and applying the programmer wand to the patient's device. After an initial introduction, communication was established and continued via the wand connection. The remote device specialist logged into the 5G-cloud follow-up app with two-step verification. The remote device specialist then had complete control of the programmer to check and reprogram the device as needed.
| Study group | Role | What they receive |
|---|---|---|
| 5G cloud follow-up & Routine follow-up | Experimental | CIED patients undergo both 5G cloud follow-up and routine in-office follow-up during each visit. Receives: Other: Routine Management; Device: 5G Cloud Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameter Measurement Consistency
Subjects underwent in-office follow-up and 5G cloud follow-up to test battery parameters (battery voltage, battery current, and magnet frequency) and lead parameters (amplitude, pacing threshold, and impedance) in the immediate postoperative period, prior to discharge from the hospital, and within 1 month of implantation, within 1 to 3 months of implantation, at 6 months of implantation, and at 12 months of implantation, respectively. The consistency of each parameter measured at both follow-up modalities was analyzed at the end of the trial by regression fitting equations and Pearson correlation coefficients.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Parameter Measurement Time
During each follow-up, all subjects undergo separate routine in-office follow-ups and 5G cloud follow-ups. The time taken from the beginning of device interrogation to the completion of parameter testing is recorded for each follow-up.
Measured: through study completion, an average of 1 year
Program Completion Rate
Evaluation Approach: Participants undergo both in-person clinic follow-up and 5G cloud follow-up during each appointment. Researchers will evaluate and programe the device in accordance with the current guidelines. The assessment of program completion will be conducted through the Program Control Completion Assessment Form.
Completion Criteria: If all parameter reprogramming statuses are indicated as "Yes", the program control session will be deemed as complete. In cases where any program control completion status is marked as "No", the session's program control will be considered incomplete.
Program Completion Rate is calculated as follows: the number of successful programming / the total number of programming
Measured: through study completion, an average of 1 year
adverse events
Subjects are observed and recorded at any time during the study process after enrollment. Summarize the occurrence of adverse events and calculate the rate of adverse events. Participants will be continuously monitored and documented during each follow-up session. The adverse event is defined according to the "Guidelines for Reporting Adverse Events and Device Defects" in the present study. Investigators will record and summarize the occurrence of adverse events and determine the rate of adverse event incidence. The rate of adverse event is calculated as the number of participants occurring adverse event/ the total number of the participants.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start13 Nov 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- During each session, the CIED patient undergoes both the experimental and control methods.
- Masking
- None (open label)
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Cai, The Third People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652750
- Sponsor's protocol ID
- 2024-S-182-01
- Acronym
- CIED-CARE
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets in the study might be available upon reasonable request.
Publications
Xiong S, Qin S, Tong L, Long Y, Luo Y, Feng Q, Peng X, Jiang M, Xiong F, Li J, Zhang Y, Zhang Z, Liu H, Cai L. The clinical use of remote parameter testing during cardiac implantable electronic devices implantation procedures: a single center, randomized, open-label, non-inferiority trial. Front Cardiovasc Med. 2024 Mar 22;11:1364940. doi: 10.3389/fcvm.2024.1364940. eCollection 2024.
PubMed 38586175Xiong S, Li J, Tong L, Hou J, Yang S, Qi L, Chen X, Luo Y, Zhang Z, Liu H, Cai L. Realtime Remote Programming in Patients Carrying Cardiac Implantable Electronic Devices Requiring Emergent Reprogramming. Front Cardiovasc Med. 2022 May 16;9:871425. doi: 10.3389/fcvm.2022.871425. eCollection 2022.
PubMed 35651905Tong L, Xiong S, Hou J, Li J, Qin S, Zhang Y, Yang S, Qi L, Chen X, Luo Y, Zhang Z, Deng H, Liu H, Cai L. Cloud Follow-Up in Patients With Cardiovascular Implantable Electronic Devices: A Single-Region Study in China. Front Cardiovasc Med. 2022 May 9;9:864398. doi: 10.3389/fcvm.2022.864398. eCollection 2022.
PubMed 35615564Tong L, Long Y, Xiong S, Li J, Huang W, Liu H, Cai L. Application of Postoperative Remote Follow-Up of CIED Based on the 5G Cloud Technology Support Platform in Areas With Underdeveloped Medical Resources. Front Cardiovasc Med. 2022 Jun 17;9:894345. doi: 10.3389/fcvm.2022.894345. eCollection 2022.
PubMed 35783847
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices: a Prospective, Paired, Self-controlled, Non-inferiority, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06652750
- Acronym / sponsor ID
- CIED-CARE / 2024-S-182-01
- Keywords
- pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy, follow up, remote programming, in-office follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation.
Participants will:
undergo regular clinic follow-up visits in accordance with the guidelines undergo routine in-office follow-up and 5G cloud follow-up during each regular clinic visit
Detailed description
Background: Cardiovascular implantable electronic devices (CIED) include pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) pacemakers and defibrillators, implantable cardiac event recorders (ICM), and implantable cardiovascular monitors. They are mainly used for the diagnosis, monitoring, and treatment of bradycardia, tachycardia, and heart failure (HF). There are currently two main methods of follow-up: routine in-office follow-up and remote monitoring (RM). Routine in-office follow-up is the most commonly used method in China, whereby professional doctors and/or manufacturer engineers conduct follow-ups under the guidance of physicians. Remote monitoring (RM) allows patients to be remotely monitored at home or elsewhere when a communication network is available, receiving periodic alerts related to the patient. Remote monitoring (RM) can provide timely and accurate CIED data and information, promptly alerting clinical doctors to any issues. However, a drawback is that patients still need to visit the hospital for device parameter adjustments, so it only partially fulfills the functions of routine in-office follow-up. Of note, in the past three years, some domestic clinical centers in China have begun exploring the application of 5G cloud follow-up remote programming (5G Cloud Follow Up) in various patient follow-up scenarios. With the comprehensive deployment of 5G networks in China, central hospitals with specialized device programmers can establish one-to-one or one-to-many regional collaborative cloud follow-up systems with primary hospitals lacking follow-up technician through 5G networks. CIED patients only need to visit nearby primary hospitals to complete regular device follow-ups. Currently, excellent research results have been obtained in the quality control of the CIED follow-ups of a single provincial medical consortium system mainly consisting of major implantation centers. However, there is still a lack of verification results for 5G cloud follow-up remote programming in a medical consortium (MC) model covering various administrative regions in China and different levels of primary hospitals. This study will compare the safety and effectiveness of using 5G cloud follow-up remote programming in different administrative regions and levels of primary hospitals in China with routine in-office follow-ups.
Objective:
This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation.
Participants will:
undergo regular clinic follow-up visits in accordance with the guidelines undergo routine in-office follow-up and 5G cloud follow-up during each regular clinic visit
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During each session, the CIED patient undergoes both the experimental and control methods.
| Arm | Type | Receives |
|---|---|---|
| 5G cloud follow-up & Routine follow-up | Experimental | Other: Routine Management, Device: 5G Cloud Follow-upCIED patients undergo both 5G cloud follow-up and routine in-office follow-up during each visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years, gender unspecified;
- Patients who have not undergone their first clinic follow-up after the implantation of cardiovascular implantable electronic devices (CIED); Note: In this study, CIED includes pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D), excluding implantable cardiac event recorders (ICM) and implantable cardiovascular monitors.
- Willing to participate in this clinical study and have signed the informed consent form in writing.
Key exclusion criteria (4 listed)
- Life expectancy < 1 year.
- Inability to cooperate with treatment or follow-up, such as having mental illness.
- Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine ManagementConducting routine in-office follow-up for CIED paitents | Other | 5G cloud follow-up & Routine follow-up |
| 5G Cloud Follow-upThis study employed a 5G-cloud follow-up platform, a research tool that allows a device specialist to test, and program CIEDs in real-time from a remote location via an internet connection or mobile wireless network. Consistent with of the 5G remote support terminal externally connected to the programmer, a PAD was installed with a 5G-cloud follow-up app. The onsite medical staff began the cloud follow-up session by contacting the remote device specialist via video call. The connection to the CIED was made by the medical staff through the use of a standard programmer. He was in charge of turning on the programmer and applying the programmer wand to the patient's device. After an initial introduction, communication was established and continued via the wand connection. The remote device specialist logged into the 5G-cloud follow-up app with two-step verification. The remote device specialist then had complete control of the programmer to check and reprogram the device as needed. | Device | 5G cloud follow-up & Routine follow-up |
Primary outcome
Parameter Measurement Consistency
Time frame: through study completion, an average of 1 year
Subjects underwent in-office follow-up and 5G cloud follow-up to test battery parameters (battery voltage, battery current, and magnet frequency) and lead parameters (amplitude, pacing threshold, and impedance) in the immediate postoperative period, prior to discharge from the hospital, and within 1 month of implantation, within 1 to 3 months of implantation, at 6 months of implantation, and at 12 months of implantation, respectively. The consistency of each parameter measured at both follow-up modalities was analyzed at the end of the trial by regression fitting equations and Pearson correlation coefficients.
3 secondary outcomes
Parameter Measurement Time
Time frame: through study completion, an average of 1 year
Program Completion Rate
Time frame: through study completion, an average of 1 year
adverse events
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 38586175Xiong S, Qin S, Tong L, Long Y, Luo Y, Feng Q, Peng X, Jiang M, Xiong F, Li J, Zhang Y, Zhang Z, Liu H, Cai L. The clinical use of remote parameter testing during cardiac implantable electronic devices implantation procedures: a single center, randomized, open-label, non-inferiority trial. Front Cardiovasc Med. 2024 Mar 22;11:1364940. doi: 10.3389/fcvm.2024.1364940. eCollection 2024.
- Background: PubMed 35651905Xiong S, Li J, Tong L, Hou J, Yang S, Qi L, Chen X, Luo Y, Zhang Z, Liu H, Cai L. Realtime Remote Programming in Patients Carrying Cardiac Implantable Electronic Devices Requiring Emergent Reprogramming. Front Cardiovasc Med. 2022 May 16;9:871425. doi: 10.3389/fcvm.2022.871425. eCollection 2022.
- Background: PubMed 35615564Tong L, Xiong S, Hou J, Li J, Qin S, Zhang Y, Yang S, Qi L, Chen X, Luo Y, Zhang Z, Deng H, Liu H, Cai L. Cloud Follow-Up in Patients With Cardiovascular Implantable Electronic Devices: A Single-Region Study in China. Front Cardiovasc Med. 2022 May 9;9:864398. doi: 10.3389/fcvm.2022.864398. eCollection 2022.
- Background: PubMed 35783847Tong L, Long Y, Xiong S, Li J, Huang W, Liu H, Cai L. Application of Postoperative Remote Follow-Up of CIED Based on the 5G Cloud Technology Support Platform in Areas With Underdeveloped Medical Resources. Front Cardiovasc Med. 2022 Jun 17;9:894345. doi: 10.3389/fcvm.2022.894345. eCollection 2022.
- Individual participant dataSharing planned: Undecided. The datasets in the study might be available upon reasonable request.
Related trials for Sick Sinus Syndrome
Recruiting
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
Sinus Pause, Sinus Sick Syndrome
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Recruiting
LEAP 2 Chronic EFS
Cardiac Pacemaker, Cardiac Rhythm Disorder
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Management and 5G Cloud Follow-up in people with Sick Sinus Syndrome and Atrioventricular Block, Second and Third Degree, run by The Third People's Hospital of Chengdu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Cai, master of medicine (8619980510703, clin63@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameter Measurement Consistency (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652750, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.